Singapore HSA registration DE0504311
Arthrex BioComposite Tenodesis Screws
Singapore·CLASS D·Arthres, Inc.·Registered April 02, 2020Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0504311
- Registration Date
- April 02, 2020
- Retention Due Date
- April 01, 2026
Product description
Intended for fixation of ligament and tendon graft tissue in Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Medial/Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle. Knee: Anterior/Posterior Cruciate Ligament Repair, Medial/Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment,Ulnar/Radial Collateral Ligament Reconstruction.Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist, Carpometacarpal joint arthroplasty (basal thumb arthroplasty).
Product Owner
- Name
- Arthres, Inc.
- Short Name
- Arthres, Inc.
- Address
- 1370 Creekside Boulevard, Naples, Florida, 34108-1945, UNITED STATES
Registrant
- Address
- 21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
- Address
- Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model information
- Model Name(s)
- BioComposite Tenodesis Screw w/ Handled Inserter,3 mm × 8mm BioComposite Tenodesis Screw, 4 mm × 10 mm BioComposite Tenodesis Screw, 4.75 mm × 15 mm BioComposite Tenodesis Screw, 5.5 mm × 15 mm BioComposite Tenodesis Screw, 6.25 mm × 15 mm BioComposite Tenodesis Screw, 7 mm × 23 mm BioComposite Tenodesis Screw, 8 mm × 23 mm BioComposite Tenodesis Screw, 9 mm × 23 mm BioComposite Tenodesis Screw, 7 mm × 10 mm BioComposite Tenodesis Screw, 8 mm × 12 mm
- Model Identifier(s)
- AR-1530BC AR-1540BC AR-1547BC AR-1555BC AR-1562BC AR-1570BC AR-1580BC AR-1590BC AR-1670BC AR-1680BC
About this record
Access comprehensive regulatory information for Arthrex BioComposite Tenodesis Screws in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504311 and owned by Arthres, Inc.. The device was registered on April 02, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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